CARBOMEDICS STANDARD M7-021Recalls & reported problems
Corcym Srl · Class 3 · Implant
All models of CARBOMEDICS STANDARD (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057012692), received between Sep 2, 2020 and Sep 2, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2009 A PATIENT RECEIVED A CARBOMEDICS STANDARD M7-021 MECHANICAL HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS STANDARD M7-027. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Information
MAUDE report 10485501 ↗InjurySep 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2009 A PATIENT RECEIVED A CARBOMEDICS STANDARD M7-021 MECHANICAL HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS STANDARD M7-027. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Information
MAUDE report 10485498 ↗
Other HEART-VALVE, MECHANICAL devices
- On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33On-X Life Technologies, Inc. · Heart-Valve, Mechanical1 recall1 death34 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths70 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL5 deaths66 reports
- SJM Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths44 reports
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021Corcym Srl · HEART-VALVE, MECHANICAL7 deaths37 reports
- Regent™ 21AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths35 reports
- Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL2 deaths33 reports
- Regent™ 19AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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